Repros Updates Androxal(R) Global Regulatory Status
29 déc. 2014 16h15 HE
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Repros Therapeutics Inc.
Full response to November meeting submitted to FDA
Repros believes all FDA questions positively addressed
Company expects contract organization to officially submit NDA to FDA...
Repros Initiates Two Phase 2B Uterine Fibroid Studies
29 déc. 2014 16h15 HE
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Repros Therapeutics Inc.
Low dose oral Proellex® study in women with fibroids and heavy menstrual bleeding initiated
Vaginal administration of Proellex® in women with fibroids and heavy menstrual bleeding...
Court Rules Inventors Correctly Named on Androxal(R) Patents
29 déc. 2014 09h15 HE
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Repros Therapeutics Inc.
THE WOODLANDS, Texas, Dec. 29, 2014 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced a federal judge in Texas has issued a definitive ruling finding correct...
Repros Therapeutics Inc.(R) Reports Third Quarter 2014 Financial Results
10 nov. 2014 09h00 HE
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Repros Therapeutics Inc.
THE WOODLANDS, Texas, Nov. 10, 2014 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced financial results for the third quarter ended September 30, 2014.
Financial...
Repros Holds Constructive Meeting With FDA Regarding Androxal(R) NDA Filing
06 nov. 2014 16h15 HE
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Repros Therapeutics Inc.
No New Clinical Studies Requested
Environmental Impact Assessment Plan Will be Discussed With FDA Prior to NDA Submission
Company to Host Conference Call on Friday, November 7,...
Repros to Webcast Investor and Analyst Day on October 31st
27 oct. 2014 16h01 HE
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Repros Therapeutics Inc.
THE WOODLANDS, Texas, Oct. 27, 2014 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today announced that it will host a live webcast of its Investor and Analyst Day that is being held...
Results From Long-Term Study of Androxal(R) Exhibit Positive Safety Profile
21 oct. 2014 16h01 HE
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Repros Therapeutics Inc.
No evidence of negative effects on bone mineral density
Treatment benefit is sustained with 79.3% of subjects exhibiting normal morning testosterone after 12 months of treatment (LOCF...
Upcoming FDA Meeting to be Type C Meeting
16 oct. 2014 20h01 HE
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Repros Therapeutics Inc.
THE WOODLANDS, Texas, Oct. 16, 2014 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today reported that its upcoming meeting with the FDA in the first half of November will be a Type...
FDA Schedules Type B Pre-NDA Meeting With Repros
26 sept. 2014 06h45 HE
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Repros Therapeutics Inc.
THE WOODLANDS, Texas, Sept. 26, 2014 (GLOBE NEWSWIRE) -- Repros Therapeutics Inc.® (Nasdaq:RPRX) today reported it has been granted a Type B Pre-NDA meeting with the FDA in the first half of...
Androxal(R) Second Pivotal Study Achieves Superiority in Top Line Analysis for Both Co-Primary Endpoints Versus Marketed Topical Gel in the Treatment of Secondary Hypogonadism
25 sept. 2014 20h20 HE
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Repros Therapeutics Inc.
44.2% of Topical T subjects below 10 million sperm/mL at end of study versus 2.4% and 0.0% respectively for Androxal® and placebo ITT (Androxal® vs. Topical T, p < 0.0001)
71.5%...